The U.S. FDA has cleared Medivis’ Cranial Navigation platform, the first augmented reality system approved for cranial neurosurgery. The clearance builds on the agency’s earlier approval of the company’s Spine Navigation system.

Cranial Navigation projects patient imaging directly onto the surgical field, giving surgeons a real-time view of anatomy and planned trajectories. Unlike conventional navigation systems, it removes the need to look away at external monitors, preserving focus and streamlining workflow.

Portability extends use beyond the operating room to the bedside and intensive care units, where conventional navigation is often impractical. This matters for external ventricular drain (EVD) placement, which can be misplaced in up to 30% of cases—delaying care, requiring repeat passes, and increasing patient risk. Early clinical experience suggests augmented reality guidance may reduce these errors.
The platform maps patient-specific 3D imaging directly into the operative field, allowing surgeons to visualize complex anatomy, plan precise trajectories, and place catheters with greater spatial accuracy.

“For the first time, neurosurgeons can perform cranial procedures using augmented reality,” said Osamah Choudhry, MD, CEO and cofounder of Medivis.

Christopher Morley, MD, president and cofounder, highlighted the platform’s versatility. “This milestone reflects close collaboration with the FDA and underscores broader use of AR guidance in ICUs, ORs, and surgical centers,” he said.

Cranial Navigation combines computer vision, image segmentation, and real-time processing to provide context-aware guidance throughout procedures. Lightweight hardware keeps imaging in the surgeon’s line of sight without disrupting workflow, addressing long-standing challenges where conventional navigation is difficult to deploy.

The system may be eligible for reimbursement under CPT add-on code 61781, while Spine Navigation aligns with 61783. With the FDA clearance, it adds another real-time guidance option for neurosurgery, integrating imaging directly into intraoperative decision-making.

“Medivis’ mission is to transform the standard of care in procedural healthcare,” a company spokesperson said. “Medivis is moving from ‘future potential’ to a present standard.”

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